FDA Protests Firm's Letters About Implants

[Guest guest]

It looks like the FDA's approval is at hand! . . . I

suspect they will wait until a Friday afternoon, or

the holidays to make the announcement in the hope the

announcement will get overlooked.

It may be time to prepare letters for the media to let

them know how little regard the manufacturer's,

plastic surgeons and the FDA have for women and

children's health and welfare!

Rogene

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http://www.washingtonpost.com/wp-dyn/content/article/2005/11/01/AR2005110101669.\

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FDA Protests Firm's Letters About Implants

By Marc Kaufman

Washington Post Staff Writer

Wednesday, November 2, 2005; Page A10

The Food and Drug Administration has objected to a

letter sent last week by a manufacturer of

silicone-gel breast implants advising doctors that

approval of its controversial product was imminent,

causing Mentor Corp. to send out a second letter two

days later retracting the first.

The letters, and the agency's response, indicate the

long regulatory battle over silicone implants may be

nearing an end and that the companies that make the

implants are jockeying for position as a lucrative

market reopens after 13 years of tight sales

limitations.

The faxes sent to plastic surgeons included a cover

letter telling them to make sure their patients knew

that the silicone gel implants had been approved and

urging them to stay enrolled in a long-running

clinical trial of the implants. A second page,

described by Mentor as " approved by the FDA, " details

some conditions attached to the approval.

Among them was a restriction against selling silicone

implants for breast enlargement to women younger than

22. The implants would be available to women of any

age for breast reconstruction surgery because of

cancer or injury.

The FDA did not formally comment on the Mentor

letters, except to say that no formal decision has yet

been made. But an FDA official, speaking on the

condition he not be identified because of the

sensitivity of the issue, confirmed that agency

officials were concerned about the Mentor letters, and

said that the information in them is incorrect.

Josh Levine, Mentor's president and chief executive,

said yesterday that the initial letters had been

drafted to be sent " upon notification of a potential

FDA decision " and that Mentor's application " is still

under review and has not yet been approved. "

" This correspondence was mistakenly sent to the study

investigators, " he said of the letters. " Upon learning

of the error, Mentor took steps immediately to correct

the mistake. . . . We have resolved the issue to FDA's

satisfaction. "

Mentor and Inamed Corp., both of California, received

" approvable " letters from the FDA this year indicating

that their products would be allowed on the market if

certain conditions were met. The agency did not give

any time frame for a final decision.

Sales of silicone-gel breast implants were restricted

by the FDA in 1992 because of concern that they might

cause immune system disorders. Subsequent study has

lessened concerns over long-term dangers, but a

contentious battle over the implants' use continued.

The FDA has held several lengthy advisory panel

hearings in recent years, which featured emotional

testimony by opponents who alleged terrible harm from

silicone implants and pleas from supporters who said

all women -- and especially women undergoing

reconstruction after surgery -- should be allowed to

choose silicone implants. Silicone implants are

generally preferred over the saline implants on the

market.

Some of the major reservations voiced by the FDA and

advisory panel experts involved the relatively limited

amount of long-term information about the implants'

effects on women's bodies. Both Mentor and Inamed have

committed to continuing studies of future

complications if their implants are approved. The

unusual letters sent out last week by Mentor involved

efforts to make sure patients remain in their studies.

The cover letter began: " In anticipation of a final

gel breast approval, the FDA is requiring that [study]

doctors send a letter to their study patients

notifying them of the gel approval, and to remind them

of the importance of their commitment to continue

their 1-, 3-, and 5-year follow-up visits. " The letter

was signed by lyn Cole, manager for the studies.

Her letter described an attached letter, titled

" SAMPLE LETTER -- Contingent on Final FDA Approval of

Devices, " saying it had been approved by the FDA.

The Mentor letters were criticized yesterday by Nick

Teti, president of Inamed.

" We are very disappointed to learn about this

situation, given how this clearly has a disruptive

effect on the patients and physicians, " he said.